An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients >= 65 Years With Acute Myeloid Leukemia
Overview
- Phase
- Phase 1
- Intervention
- decitabine iv
- Conditions
- Leukemia, Myeloid, Acute
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 13
- Locations
- 3
- Primary Endpoint
- Number of Subjects With Dose Limiting Toxicities (DLT) in Cycle 1
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients >= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status.
MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML >= 65 years of age and considered ineligible for standard intensive therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
volasertib + decitabine
dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))
Intervention: decitabine iv
volasertib + decitabine
dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))
Intervention: volasertib iv infusion
Outcomes
Primary Outcomes
Number of Subjects With Dose Limiting Toxicities (DLT) in Cycle 1
Time Frame: 4 weeks
Number of subjects with Dose Limiting Toxicities (DLT) in Cycle 1 is presented
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1
Time Frame: 4 weeks
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with decitabine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and decitabine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1.